HYDERABAD | MUMBAI | AHMEDABAD-GANDHINAGAR | RAJKOT
- In a regulatory updates submitted to the Indian Stock Exchanges, Hyderabad headquartered Indoco Remedies Ltd's Clinical Research Organization (CRO) has been inspected by USFDA (US Food and Drugs Administration) and cleared being granted Establishment Inspection Report (EIR).
In a press-release as submitted by the company to the Indian Bourses, titled - "Indoco’s CRO – AnaCipher receives EIR from USFDA" further read that, Indoco Remedies Ltd. announced today, the receipt of Establishment Inspection Report (EIR) for its Clinical Research Organisation, AnaCipher, located at Hyderabad for the inspection carried out by the United States Food and Drug Administration (division of New Drug Bioequivalence Evaluation) from 5th August to 9th August, 2019.
The inspection was successfully conducted without any observations and stands closed now.
The CRO - AnaCipher conducts Bioequivalence and Bioavailability (BA/BE) studies at its facility spread over an area of 30,000 sq. ft. with 98 beds.
The CRO also has expertise in Bioanalytical work for new chemical entities (Phase I-III studies).
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